September 2015

Author:
Erika Huffman, MSBME, RAC, Principal Medical Research Manager, NAMSA

Abstract:

Prior to submitting an investigational device exemption (IDE) application or other premarket submission, the US Food and Drug Administration (FDA) recommends using the Pre-Submission (Pre-Sub) program to obtain feedback on the submission. This process can be useful for novel devices and device sponsors who are new to premarket submissions.

The pre-IDE program was first established in 1995 to provide feedback on IDE submissions and has become the most commonly used method of obtaining FDA feedback prior to a premarket device submission.